Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry

Pain Clinical Trial

— Analgesia  

Official title:

Does Preventive Analgesia Improve the Outcome of Demerol-Vistaril Procedural Sedations in Pediatric Dentistry?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01971853
• Other study ID #: 13-1753
• Status: Terminated
• Phase: N/A
• Start date: October 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: December 2020
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

All healthcare providers strive continually to improve the outcome of their treatment approaches. The investigators hypothesize that preventive analgesics administered before a child is sedated with a Demerol-Vistaril regimen will improve the outcome of a sedation.

Description:

To increase outcomes for patients receiving dental sedation by providing significant evidence that the new regimen improves the quality of sedation and results in an improved post sedation ability to eat, drink, resume normal activities and require less additional pain medications.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 88
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

Inclusion Criteria:

• We intend to enroll 300 children between the ages of 2 - 8 years of all ethnicities for this prospective, placebo controlled, randomized, and double-blind trial. All children that fulfill our general selection criteria for this sedation regimen will be eligible for this study.

Exclusion Criteria:

• Children who do not meet our general selection criteria for this sedation regimen will be ineligible for this study.

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• oral placebo
Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen
• Oral Analgesics
Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time of Administration of Nitrous Oxide and Oxygen as Measured by Minutes and Percent of Nitrous Oxide Administered	The differences in time and concentration of nitrous oxide used during treatment will be compared for each study arm.	From start of treatment (time 0) to 60 minutes
Other	Complexity of Procedures Completed as Measured by Numerical Value Using Procedure Complexity Scale in Description	A table will be used to determine the complexity of procedures performed by assigning a numerical value to each procedure and determining a total procedure complexity score.	60 minutes after start of treatment
Other	Complications During Treatment and Recovery	The occurrence of Complications during treatment and recovery will be evaluated. Complications are defined as vomiting, excessive crying, need for supplemental oxygen, and disorientation.	2 hours in clinic
Other	Post Operative Problems	Presence of Post op problems including time and whether problem is constant or intermittent will be as follows: Discomfort when eating/drinking (D), Resumption of normal activity (NA), and Need for additional pain meds (PM)	4 hours after patient is discharged
Primary	Improved Sedation Effectiveness Based on Numerical Value for Effectiveness as Noted in Description	A Sedation effectiveness evaluation criteria chart will be utilized to determine a numerical value for the effectiveness as follows: 1 = Effective/Excellent; 2 = Partially effective/good; 3 = Ineffective/fair; 4 = Aborted/Poor	60 minutes treatment started
Secondary	Difference in Heart Rate as Measured by Numerical Delta Value	A baseline heart rate will be determined at the beginning of the appointment, and a maximum heart rate will be determined during the appointment. The differences between baseline and maximum heart rates for each study arm will be compared.	From state of treatment (time 0) 60 minutes